Complaint conclusion: the 34mm aaa bifurcate main body iliac graft got severely occluded.Iliac needed to be reworked due to stenosis.The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿in-stent peripheral artery restenosis¿ and ¿stent occlusion¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics or procedural factors may have contributed to the reported event but these remain unknown despite follow-ups.According to the safety information in the instructions for use ¿potential adverse events and potential device risks include, but are not limited to prosthesis occlusion/stenosis.Follow up procedure it is recommended that physicians conduct regular examinations and imaging for the patient¿s lifetime.Follow-up imaging should be decided based upon the physician¿s clinical assessment of the patient pre- and post-implantation of the stent graft.After endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.Annual imaging is recommended, including abdominal radiographs to examine device integrity (stent fracture, separation between bifurcated device and proximal cuffs or limb extensions, if applicable); and contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease.If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.¿ neither the phr nor the very limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
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